Gemcitabine+ Capecitabine Vs Capecitabine in Curatively Resected Biliary Tract Cancer

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Brief Title

Gemcitabine+ Capecitabine Vs Capecitabine in Curatively Resected Biliary Tract Cancer

Official Title

A Randomized, Multi-center Phase III Trial of Adjuvant Chemotherapy With Gemcitabine and Capecitabine Compared to Capecitabine Alone in Curatively Resected Biliary Tract Cancer

Brief Summary

      This clinical trial is an open-label, multicenter, phase 3 clinical trial to study the
      efficacy and safety of adjuvant gemcitabine + capecitabine combination treatment in patients
      with resectable biliary tract cancer according to imaging studies after surgery. All the
      patients must complete a consent forms before participating in the clinical trial, and the
      estimated enrollment period is 36 months after IRB approval.

      Drug Dose and Schedule:

        -  Cohort 1: Gemcitabine/Capecitabine, every 4 weeks, total 6 cycles gemcitabine1,000 mg/m2
           over 30 min D1, D8, D15 capecitabine 1660 mg/m2, D1-21

        -  Cohort 2: Capecitabine, everu 3 weeks, total 8 cycles capecitabine 2,500 mg/m2 D1-14
    

Detailed Description

      1. Study Background & Rationale:adjuvant capecitabine monotherapy following surgery is
           regarded as standard treatment after phase 3 BILCAP trial, we need further phase 3
           clinical trials to evaluate efficacy of doublet combination adjuvant chemotherapy for
           Biliary Track Cancer after surgery. Since Korea has much higher incidence rate of
           Biliary Track Cancer compared to western countries, Korea is considered to be a region
           that can lead large-scale Biliary Track Cancer clinical trials. In this background, we
           intend to conduct a randomized phase 3 study to compare adjuvant gemcitabine+cisplatin
           combination therapy with camecitabine monotherapy following curative intent surgical
           resection in patients with Biliary Track Cancer .

        2. Primary Objective:

             -  Disease-free survival at 24 months (2-year DFS)

        3. Primary Hypothesis:

           Adjuvant gemcitabine and capecitabine combination treatment confers diseae free survival
           benefit over capecitabine monotherapy after curative intent surgical resection of
           biliary tract cancer

        4. Study Design:

      This clinical trial is an open-label, multicenter, phase 3 clinical trial to study the
      efficacy and safety of adjuvant gemcitabine + capecitabine combination treatment in patients
      with resectable biliary tract cancer according to imaging studies after surgery. All the
      patients must complete a consent forms before participating in the clinical trial, and the
      estimated enrollment period is 36 months after IRB approval.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Two-year disease free survival (DFS)

Secondary Outcome

 Overall Survival (OS)

Condition

Biliary Tract Cancer

Intervention

Gemcitabine/Capecitabine

Study Arms / Comparison Groups

 Gemcitabine/Capecitabine
Description:  gemcitabine1,000 mg/m2 over 30 min D1, D8, D15 capecitabine 1660 mg/m2, D1-21

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

490

Start Date

January 1, 2021

Completion Date

March 30, 2025

Primary Completion Date

March 30, 2025

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with histologically confirmed adenocarcinoma of biliary tract canacer
             (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder
             cancer) after curative intent R0 or R1 surgical resection

          2. Pathologic disease stage of T2-4, N0-2, M0 after surgery, according to AJCC 8th TNM
             staging

          3. Patients who complete resection (R0 or R1 resection) for biliary tract cancer within
             12 weeks of the adjuvant chemotherapy

          4. No distant metastasis

          5. ECOG performance sstatus score of 0 or 1

          6. Age 19 years or older

          7. Adequate bone marrow fuction (neutrophils ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L and
             hemoglobin ≥9 g/dL)

          8. Adequate liver function (total bilirubin < 1.5 fold the upper limit of normal of the
             study site (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) <
             5.0 x ULN)

          9. Adequate kidney function (Creatinine < 1.5 x ULN)

         10. Unresolved systemic active infection (except for chronic viral hepatitis taking
             antiviral drugs)

         11. Not receiving other drugs for clinical trials or chemotherapy within 30 days prior to
             randomization

         12. A female participant who is not post-menopausal or amenorrhea less than 12 consecutive
             months without specific reasons is eligible to participate if she is not pregnant,
             confirmed by serum tests within 7 days before the initiation of chemotherapy

         13. The participants provide written informed consent for the study.

         14. No prior chemotherapy for biliary tract cancer

         15. Participants of childbearing potential must agree to use an adequate method of
             contraception for the course of the study throught 120 days after the last dose of
             chemotherapy (oral contraceptives or mechanical contraception such as intrauterine
             devices or contraceptive barriers and etc). Childbearing potential female is who is
             not post-menopausal or amenorrhea less than 12 consecutive months without specific
             reasons

        Exclusion Criteria:

          1. Other histology type than adenocarcinoma (such as HCC-CCC mixed type or neuroendocrine
             tumor)

          2. Ampula of vater cancer

          3. Has known additional malignancy (participants with non-melanoma skin cancer, or
             carcinoma in situ (e.g. breast carcinoma, prostate cancer) that have undergone
             potentially curative therapy without recurrence for more than 3 years are not
             excluded)

          4. Has a history or current evidence of any condition, therapy, or laboratory abnormality
             that might confound the results of the study, interfere with the subject's
             participation for the full duration of the study, or is not in the best interest of
             the subject to participate, in the opinion of the treating investigator.

          5. Has an active infection requiring systemic therapy (bacteria, virus, fungal, etc)

          6. Has a known history of Human Immunodeficiency Virus (HIV)

          7. Has an active of hepatitis A or B (patients under anti-B-viral treatment with HBV DNA
             1000≤copies/ml is allowed to particiapte).

          8. Has a history of severe hemorrhage (gastrointestinal or neurologic) within 2 weeks
             prior randomization

          9. Is unable to take oral drug due to gastrointestinal obstruction or any other
             conditions.

         10. Any history of significant cardiac disease within 3 months prior to randomization
             including unstable angina, NYHA (The New York Heart Association )III or IV congestive
             heart failure, myocardiac infarction, or severe uncontrolled arrhythmias

         11. Pregnant, breast-feeding or pregnancy test positive female patients

         12. Has any contraindications for investigational drug

               -  History of hypersensitivity to capecitabine or gemcitabine

               -  Any hypersensitivity to fluorouracil drugs

               -  Concurrent administration with sorivudine or brivudine

               -  DPD(dihydro-pyridine dehydrogenase) deficiency

               -  History of TS-1(tegafur / gimeracil / oteracil) administration

               -  Galactose intolerance, Lapp lactase deficince, glucose-galactose malabsorption

               -  Interstitial pneumonia or pulmonary fibrosis
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 82-2-3410-3459, [email protected]



Administrative Informations


NCT ID

NCT04401709

Organization ID

2020-01-101


Responsible Party

Principal Investigator

Study Sponsor

Samsung Medical Center


Study Sponsor

, , 


Verification Date

December 2020